November 2020 FDA Recall Drug by Invatech Pharma Solutions, Llc
D-0115-2021 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Invatech Pharma Solutions, Llc on November 11, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0115-2021

Reason for Recall
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Initiated
11-11-2020
Reported
12-09-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86708
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
InvaTech Pharma Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-20-2023
Product Description About Product Description
Full technical description of the product.
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30

Batch or Lot Expiration Information

Lot# : 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022